Purpose
The purpose of this study was to evaluate the clinical efficacy and safety of treating
patients with a cartilage defect of the knee with microfractures and porcine-derived
collagen-augmented chondrogenesis technique (C-ACT).
Methods
One hundred participants were randomly assigned to the control group (n = 48, microfracture)
or the investigational group (n = 52, C-ACT). Clinical and magnetic resonance imaging
(MRI) outcomes were assessed 12 and 24 months postoperatively for efficacy and adverse
events. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) assessment
was used to analyze cartilage tissue repair. MRI outcomes for 50% defect filling and
repaired tissue/reference cartilage (RT/RC) ratio were quantified using T2 mapping.
Clinical outcomes were assessed using the visual analogue scale (VAS) for pain and
20% improvement, minimal clinically important difference (MCID), and patient acceptable
symptom state for Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International
Knee Documentation Committee score.
Results
MOCART scores in the investigation group showed improved defect repair and filling
(P = .0201), integration with the border zone (P = .0062), and effusion (P = .0079). MRI outcomes showed that the odds ratio (OR) for ≥50% defect filling at
12 months was statistically higher in the investigation group (OR 3.984, P = .0377). Moreover, the likelihood of the RT/RC OR becoming ≥1 was significantly
higher (OR 11.37, P = .0126) in the investigation group. At 24 months postoperatively, the OR for the
VAS 20% improvement rate was significantly higher in the investigational group (OR
2.808, P = .047). Twenty-three patients (52.3%) in the control group and 35 (77.8%) in the
investigation group demonstrated more than the MCID of KOOS pain from baseline to
1 year postoperatively, with a significant difference between groups (P = .0116).
Conclusion
In this multicenter randomized trial, the addition of C-ACT resulted in better filling
of cartilage defect of the knee joint.
Level of Evidence
Level Ⅰ, Multicenter Randomized Controlled Trial
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Article info
Publication history
Published online: November 27, 2019
Accepted:
November 16,
2019
Received:
May 21,
2019
Footnotes
See commentary on page 1625
The authors report the following potential conflicts of interest or sources of funding: This study was funded by Sewon Cellontech. None of the authors have received reimbursements or salary from Sewon Cellontech. None of the authors hold any stocks or shares. Full ICMJE author disclosure forms are available for this article online, as supplementary material.
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Copyright
© 2019 by the Arthroscopy Association of North America
ScienceDirect
Access this article on ScienceDirectLinked Article
- Editorial Commentary: Cartilage Restoration—What Is Currently Available?ArthroscopyVol. 36Issue 6
- PreviewIn the past 30 years, bone marrow stimulation techniques such as microfracture (MF) have become a popular method to treat symptomatic focal articular cartilage lesions. Nonetheless, recent studies have not shown good long-term clinical outcomes, and MF has produced alterations in the subchondral bone architecture with degenerative changes. Autologous chondrocyte implantation (ACI) has shown good results at 20 years. Second- and third-generation ACI has shown superiority to MF and fewer complications than first-generation ACI.
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